Post by Medical Device Network

Xeltis has gained a European CE mark for aXess, with 12-month pivotal data of the vascular access graft for haemodialysis demonstrating strong and higher secondary patency versus conventional arteriovenous grafts (AVGs). Xeltis’s aXess is a bioabsorbable graft for haemodialysis that is injected under the skin, promoting the growth of a patient’s own tissue to form a living, permanent blood vessel. With the CE mark in hand, the Netherlands-based company intends to initiate commercial activities for its graft across Europe. Xeltis CEO, Eliane Schutte, said: “The data demonstrate that aXess is safe and easy to implant, and by 12 months transforms into a tissue-like, pulsating conduit. With this level of clinical evidence, we can now move forward with the commercialisation of aXess and begin delivering it to patients in real-world clinical practice.” #vascularaccess #medtech #haemodialysis #CEmark Read the full report below: https://lnkd.in/en6NbgWX